Sustaining Quality Director
Core
Provide leadership and direction to the Sustaining Quality organization to ensure quality and compliance for commercial products and associated Quality Management System processes.
Role type
Senior management director of sustaining quality
Builds
Commercial product quality systems and remediation programs
Domain
Medical device / Pharmaceutical / Regulated healthcare
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic planning, risk-based portfolio management, cross-functional program leadership, systemic process improvement, executive reporting, budgetary management, hiring and staff development
Preferred skills
Enterprise quality function establishment, blended workforce leadership, regulatory operating model design
Technologies
Microsoft Excel, 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, MDR
Responsibilities
Develop and implement strategy and operating model for Sustaining Quality; Lead complex cross-functional remediation and product lifecycle quality programs; Establish risk-based portfolio management and execution controls; Identify systemic gaps and partner to implement sustainable improvements; Act as liaison with senior leadership and cross-functional teams; Oversee inspection and audit readiness; Develop and maintain performance measures and executive reporting; Lead, develop, and allocate internal and contract resources
Seniority
Senior, strategic management with direct reports